Dr. Sharman on the Design of the ELEVATE-TN Trial in CLL

Jeff Sharman, MD, director of research at Willamette Valley Cancer Institute and medical director of hematology research for The US Oncology Network, discusses the design of the phase III ELEVATE-TN trial in patients with previously untreated chronic lymphocytic leukemia (CLL).

The trial enrolled patients ≥65 years of age or those <65 years of age with medical comorbidities that made them eligible for a less intensive chemoimmunotherapy regimen. The 3-arm study evaluated acalabrutinib (Calquence) alone or in combination withobinutuzumab (Gazyva) versus obinutuzumab/chlorambucil.

The primary endpoint was progression free survival (PFS) in the acalabrutinib/obinutuzumab arm versus the obinutuzumab/chlorambucil arm. Secondary endpoints included PFS in the acalabrutinib-alone arm versus obinutuzumab/chlorambucil, as well as safety, time to next treatment, and overall survival (OS).

The median PFS was not reached with either acalabrutinib arm. However, the PFS in the chlorambucil/obinutuzumab arm was 22.6 months (95% CI, 20.2-27.6). The 2-year PFS rates were 93%, 87%, and 47% for acalabrutinib/obinutuzumab, acalabrutinib monotherapy, and obinutuzumab/chlorambucil, respectively.

The OS in the acalabrutinib monotherapy arm (HR, 0.60; 95% CI, 0.28-1.27; P = .1556) was better than the acalabrutinib/obinutuzumab arm (HR, 0.47; 95% CI, 0.21-1.06; P = .0577; however, the benefit was not statistically significant. The 2-year OS rates were 95%, 95%, and 92% with acalabrutinib/obinutuzumab, acalabrutinib monotherapy, and obinutuzumab/chlorambucil, respectively.